Drugs Q & A

Why Was Bextra Taken Off The Market?

What is Bextra?

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) that work by reducing substances in the body that cause inflammation, pain, and fever. It was approved by the United States Food and Drug Administration on November 20, 2001.

Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation. Bextra may also be used for purposes other than those listed in this medication guide.

Why Was Bextra Taken Off The Market?

In April 2005, The United States Food and Drug Administration (FDA) and Pfizer the drug manufacturer announced the removal of Bextra from the U.S. market because studies have shown that its risks of heart, stomach, and skin complications clearly outweighed its benefits.

Bextra appears to increase the risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs. There were also safety concerns of an increased risk of rare but serious skin reactions (Stevens-Johnson syndrome) in patients taking Bextra.

In 2009 Bextra was also at the center of the largest healthcare fraud settlement and the largest criminal fine of any kind ever. Pfizer paid a $2.3 billion civil and criminal fine. Pharmacia and Upjohn, a Pfizer subsidiary, violated the United States Food, Drug, and Cosmetic Act for misbranding Bextra “with the intent to defraud or mislead.

A water-soluble and injectable prodrug of valdecoxib, parecoxib is still marketed in the European Union under the tradename Dynastat.

What are the possible side effects of Bextra?

Bextra may cause serious side effects including:

•          hives,

•          difficulty breathing,

•          swelling of your face, lips, tongue, or throat,

•          skin rash,

•          itching,

•          abdominal pain,

•          nausea,

•          bloody vomit,

•          black or tarry stools,

•          unexplained weight gain,

•          swelling,

•          fatigue,

•          yellowing of the skin or eyes (jaundice),

•          flu-like symptoms,

•          easy bruising, and

•          unusual bleeding

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Bextra include:

•          nausea,

•          diarrhea,

•          headache, and

•          upset stomach

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Bextra. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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